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AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe

by Medwaves Incorporated 510(k)

Active United States

510(k) K143203

Overview

The AveCure Microwave Coagulation-Ablation Generator is a system designed for microwave ablation and coagulation of soft tissue. It comprises a generator-controller and single-patient-use sterile antenna-probe assemblies available in four sizes: large, medium, small, and mini.

The system is supplied as a single-use, sterile device intended for use in general and plastic surgery settings. It has received FDA 510(k) clearance under K143203 with product code NEY and is classified as a Class II device under regulation number 878.4400.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143203 Date26 Aug 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
NEY
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Medwaves Incorporated

See all devices from Medwaves Incorporated →

Questions

  • What is the AveCure Microwave Coagulation-Ablation Generator used for?

    The AveCure Microwave Coagulation-Ablation Generator is designed for microwave ablation and coagulation of soft tissue in general and plastic surgery settings, using a generator-controller and single-patient-use sterile antenna-probe assemblies.

  • How is the AveCure Microwave system supplied and is it reusable?

    The system is supplied as a single-use, sterile device, meaning each antenna-probe assembly is intended for one patient only and must be discarded after use to prevent cross-contamination and ensure sterility.

  • What sizes of antenna-probes are available for the AveCure Microwave system?

    The AveCure Microwave system includes single-patient-use sterile antenna-probe assemblies in four sizes: large, medium, small, and mini, allowing flexibility for different tissue volumes and surgical needs.

  • What regulatory pathway was used for the AveCure Microwave system?

    The AveCure Microwave Coagulation-Ablation Generator received FDA 510(k) clearance under submission K143203, demonstrating substantial equivalence to a legally marketed predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K143203 24 fields · synced 22 Oct 2026